Saturday, October 7, 2017

Scam Tactics: Knowing the Differences among FDA Registered, FDA Certified, and FDA Approved

Recently, someone posted the following comment on BehindMLM

"Davie Watkins" claimed on 6-OCT-2017 that "FDA approved
Vida Divina's Coffee Line in October 2017"

Let's first examine, what did "Vida Divina" reps say about FDA? If you Google, you may find:

The search results says "FDA certified", or "FDA Approved". But what is the truth?
None of the actual results link to FDA, it's just announcements, and they can't even agree on the language. Some say "certified", some say "approved". What is the truth? As it turns out, it was NEITHER.





Searching for proof got me this photo of the founder/CEO holding up a certificate:


It says: "certificate of registration", and an FDA registration number, for Vida Divina in Azcapotzalco, Mexico City, Mexico.

It doesn't say certified. It doesn't say approved. It simply says registered.  So the claim that the company is "officially FDA certified" is wrong.

It is simply a registration of any company required to do to import anything edible into the US. The law is very clear:

The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), in relevant part, to require that facilities engaged in manufacturing, processing, packing, or holding food for consumption in the United States submit additional registration information to FDA  -- Food Facility Registration, FDA.gov
In fact, here's the same company, Registrar Corp, explaining this is a "Food and Beverage Certificate of US FDA Registration".   The certificate is in IDENTICAL format to the one shown above. It just costs $195 to get, and it is required for "dietary supplement facility" as well, which is what Vida Divina is... maker of dietary supplements.

So repeat after me...

Vida Divina is FDA REGISTERED as a dietary supplement facility

Not approved

Not certified

FDA REGISTERED  as a dietary supplement facility

So what does FDA approve? Instead of explaining it, I'll let FDA do the explaining.  Please consult FDA guide on "Is It Really 'FDA Approved'?"

And you will see in that link, it says very specifically, FDA does NOT approve dietary supplements.

FDA doesn't approve dietary supplements. Unlike new drugs, dietary supplements are not reviewed and approved by FDA based on their safety and effectiveness. -- FDA.gov

Strictly speaking, FDA only "approve" drugs and high-tech medical devices (such as defibrillators).

FDA certify certain laboratories and staff, some mammography centers, and some specific food coloring as safe for use. They don't certify food supplements.

At best, Vida Divina's "registration" simply means it is entered into an FDA database of food "importers".

It does NOT mean Approved.

It does NOT mean Certified.

It is REGISTERED (as a facility).

Not products, not people. FACILITY ONLY.


So to summarize

  • FDA Approved -- only drugs and class 3 medical devices, NOT nutritional supplements
  • FDA Certified -- only installations like mammography centers, labs, and certain types of food coloring, NOT companies or products
  • FDA Registered -- only companies and facilities that manufacture or import stuff to be consumed in the US, NOT specific products 

Any other claim is a misrepresentation.


2 comments:

  1. Kasey, Vida Divina manufactures it’s coffee in South America where it’s grown. FDA had to approve entry into the US and did so…

    ReplyDelete
    Replies
    1. Your company is a registered nutritional supplement facility. NOT certified, NOT approved. Registered.

      Your persistent use of WRONG terminology baffles me. Are you doing it on purpose?

      Delete